Cleared Traditional

K150039 - MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150039 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
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Jul 2015
Decision
174d
Days
Class 2
Risk

K150039 is an FDA 510(k) clearance for the MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL). Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 2, 2015 after a review of 174 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K150039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2015
Decision Date July 02, 2015
Days to Decision 174 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 102d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTT Panels, Test, Susceptibility, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LTT Panels, Test, Susceptibility, Antimicrobial

All 49
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K150039.
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
K243804 · Beckman Coulter, Inc. · Aug 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
K250036 · Beckman Coulter, Inc. · Aug 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
K250084 · Beckman Coulter, Inc. · Jul 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
K202343 · Beckman Coulter, Inc. · Nov 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
K201423 · Beckman Coulter, Inc. · Jun 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
K193536 · Beckman Coulter, Inc. · Mar 2020